Job Description
We are seeking a highly skilled Regulatory Compliance Specialist to join our team. As an integral member of the Quality Unit, you will be accountable for assessing change control, ensuring compliance with regulatory filings, and providing regulatory expertise and intelligence.
Main Responsibilities:
* Lead critical topics related to Regulatory Affairs (RA) and coordinate RA-related projects.
* Provide regulatory expertise to handle major Regulatory topics for the SRC team and site representatives.
* Ensure alignment of local manufacturing activities and GMP documents with regulatory filings.
* Coordinate the provision of regulatory deliverables to support regulatory submissions and responses to objections.
* Be responsible for product portfolio lifecycle management activities and technical regulatory writings.
* Provide local expertise in compliance and CMC regulatory affairs and serve as the site's point of contact for Merck Serono Regulatory Affairs CMC and Health Authorities.
* Be responsible for site manufacturing registration renewal(s) and provision of related Health Authorities certificates.
* Maintain the Site Master File and release artwork in Webcenter as Site QA (SQA).
About You:
* You hold a degree in Biologist, pharmacist or other Life Science-related discipline.
* You have relevant experience in biotechnological manufacturing.
* You possess training or education in regulatory and 2-5 years' experience interacting with regulatory agencies.
* You fluently speak and write English and French; a third European language is an advantage.
* You possess good editorial and communication skills, organisation, structure, and coordination abilities.
* You are known for being purposeful, result-driven, and collaborative.
Benefits:
* This role offers excellent opportunities for growth and development.
* You will work with a talented team of professionals.
* You will be part of a dynamic and challenging environment.